On June 8, 2022 OnCusp Therapeutics reported a licensing agreement with Multitude Therapeutics for the development and commercialization of AMT-707 (now referred to as CUSP06), a potentially highly differentiated second-in-class CDH6 antibody drug conjugate ("ADC") (Press release, OnCusp Therapeutics, JUN 8, 2022, View Source [SID1234615816]).
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Under the agreement, OnCusp obtains the exclusive global rights to lead development and commercialization of CUSP06 worldwide outside of Greater China. Multitude will receive an upfront payment as well as development, regulatory and sales milestone payments, and tiered royalties.
CDH6 (Cadherin-6 or K-cadherin) is a high-potential ADC target for multiple solid malignancies. CDH6 is highly expressed in ovarian and renal cancers, and data indicate increased CDH6 expression is also found in patients with cholangiocarcinoma, gastric cancer, thyroid cancer, and other malignancies. CDH6 is well suited as an ADC target due to its high expression in tumor tissues, limited expression in non-tumor tissues, and rapid cellular internalization of the complex upon drug binding.
CUSP06, a preclinical-stage CDH6 ADC, is composed of a proprietary antibody with high CDH6 binding affinity, a protease cleavable linker, and an exatecan payload (a potent and clinically validated topoisomerase-1 inhibitor). The linker is specially designed to accommodate the exatecan payload, generating a highly stable and homogenous ADC. The payload is not a substrate for BCRP/P-gp. In preclinical data, this linker/payload has been shown to enable a stronger "bystander effect" than competitor ADCs. CUSP06 has a drug-to-antibody ratio of approximately 8. This asset has demonstrated excellent anti-tumor efficacy across several in vivo cancer models with both high and low CDH6 expression. CUSP06 is currently in Investigational New Drug ("IND") enabling studies. OnCusp and Multitude have engaged WuXi XDC, a global CRDMO company dedicated to end-to-end bioconjugates services, as the CMC partner for CUSP06.
"We are very excited to obtain the ex-China rights for CUSP06 and partner with Multitude, a leading ADC platform company in China," said Dr. Bing Yuan, Chairman and CEO of OnCusp. "CDH6 is emerging as a promising ADC target with exciting preliminary clinical data. CUSP06 is thoughtfully designed with clearly differentiated attributes from the competition and is well positioned to be a leader in this field. We are eager to advance CUSP06 into the clinic and deliver benefits for cancer patients worldwide."
"We are thrilled to join forces with OnCusp and leverage their highly experienced preclinical and global clinical development team to bring AMT-707 (CUSP06) to patients outside of China," said Dr. Xun Meng, Chairman and CEO of Multitude. "OnCusp’s focus on generating global clinical data, management team’s successful track record in clinical development of ADCs, and rich experience in clinical-oriented translational research make them the ideal partner for this asset. We look forward to working with Oncusp to bring AMT-707 (CUSP06) to patients globally."